It’s common knowledge in the pharmaceutical industry that medicines regulators do not conduct as many inspections of foreign drug-manufacturing facilities as they might like to. For a start, FDA only has a limited ability to require foreign establishments to allow inspectors into the facilities and logistical problems also mean that inspections cannot be performed unannounced. In addition, the cost of overseas inspections can be a huge burden and regulators, like the rest of the pharmaceutical industry, are being squeezed by today’s unsettled economic environment. However, I was still surprised this week to learn at how infrequently these inspections are performed. Because of limited resources, FDA can only inspect generic-drug manufacturers outside of the US every 7 to 13 years.
The rarity of foreign inspections has also been raised in reports from the US Government Accountability Office (GAO). Although the number of overseas inspections conducted by FDA has increased since 2007 (when FDA inspected only 8% of foreign establishments subject to inspection), FDA has itself admitted that it still has a way to go.
Fortunately, this situation is set to change in the near future. FDA will soon be receiving a cash boost to help fund inspections of generic-drug manufacturing facilities via the implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA), which comes into force on October 1, 2012. FDA already receives fees from pharmaceutical manufacturers submitting applications for new, innovative prescription products, but GDUFA marks the first time that fees will also be collected from generic-drug manufacturers too. You can read more about GDUFA here. In a nutshell, GDUFA will require pharmaceutical manufacturers to pay fees when submitting applications for generic drugs to FDA.
FDA estimates that, over a 5-year period, GDUFA will provide the agency with around $299 million annually. The supplement to its budget will help to fund more frequent inspections, as well as faster reviews of applications for generic drugs. At the moment, the average review time of a new generic drug application is 31 months. FDA hopes to bring this down to 10 months in 5 years.
The number of foreign inspections has also benefitted from increased cooperation between FDA and other regulatory agencies, such as the EMA and Australia’s Therapeutic Goods Administration (TGA). A pilot phase of a project concerning joint API inspections involving EMA, FDA and the TGA ran from December 2008 to December 2011, during which nearly 100 inspection reports were shared. The regulators are continuing their cooperation with regards to API inspections and have also opened up the project to new participants.
PharmTech is currently running a poll about GDUFA. You can vote here.